BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4223421 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46984
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD NO BUTTON RESPONSE, DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. NO DISPLAY ANOMALY, UNEXPECTED NUMBERS RAMPING OR SCROLLING BAR MOVING WITH NO INPUT NOTED. INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE ON DISPLAY WINDOW CORNER AND SCRATCHED CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUTTON ERROR ALARM FROM HIS INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVELS ARE UNKNOWN. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE PRODUCT HAS BEEN RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707538 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR